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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K080380
Device Name SAS INFLUENZA A & B TEST
Applicant
Sa Scientific, Inc.
4919 Golden Quail
San Antonio,  TX  78240
Applicant Contact ROBBI PERRY
Correspondent
Sa Scientific, Inc.
4919 Golden Quail
San Antonio,  TX  78240
Correspondent Contact ROBBI PERRY
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received02/13/2008
Decision Date 07/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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